Phase II study of Capecitabine plus Oxalipatin for advanced small bowel adenocarcinoma

Yasui Hirofumi0 个研究点目标入组 17 人开始时间: 2018年11月6日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•1) Histologically confirmed unresectable or recurrent small bowel adenocarcinoma
•2) Prior chemotherapy, radiotherapy, chemoradiotherapy, hormonal therapy were not allowed, but prior use of adjuvant chemotherapy at least 6 months before evidence of recurrence was permitted
•3) Age over 20 years
•4) ECOG Performance status (PS) 2 or less (if age >= 75 years, PS 1 or less)
•5) No symptomatic CNS metastasis
•6) Adequate organ functions
•7) No clinically abnormal findings in 12-lead resting [- within 28 days before enrollment
•8) Adequate oral intake
•9) Have an estimated life expectancy of over 3 months after enrollment
•10) Available written informed consent
•11) Having evaluable evaluable lesions

•1) Intolerance of capecitabine and oxaliplatin
•2) Females who are in pregnancy, breastfeeding, with a positive pregnancy test or unwilling to use adequate contraception or males of reproductive potential
•3) With receiving treatment for active infections or with fever (body temperature >=38degc) infectious disease is doubted
•4) Intestinal paralysis, gastrointestinal obstruction, or uncontrolled diarrhea
•5) with paresis of intestine, bowel obstruction, or uncontrolled diarrhea (diarrhea interfering daily life under treatment)
•6) with serious complications (interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, uncontrolled hypertension or diabetes mellitus, etc.)
•7) With severe paresthesia dysfunction
•8) With other active cancer
•9) need continuous treatment with phenytoin or warfarin potassium
•10) receiving systemic treatment with corticosteroids
•11) Patients whom primary physicians deems are not appropriate for this study

发起方

Yasui Hirofumi